WEEE2 Directive Puts Medical Device Industry on Notice

July 26, 2012 – 4:37 pm

Medical equipment has been largely exempt from meeting the recovery and recycling targets of the Waste Electrical and Electronic Equipment (WEEE) directive, but those days are numbered. The long-awaited revision of the directive, dubbed WEEE2, was published in the Official Journal on 24 July 2012. It contains a number of aspects that have consequences for the medical device industry, writes Andy Vaughan, Eucomed Environment Consultant, on the Eucomed blog.

The most significant change from the previous version is a reduction from the current 10 equipment categories to six after the transition period, which ends on 14 August 2018, notes Vaughan. (Sister directive 2011/65/EU on the Restriction of Hazardous Substances (RoHS2) retains the original 10 categories, which it derived from the WEEE directive.) The abridged set of categories are as follows:

  1. Temperature exchange equipment
  2. Screens, monitors and equipment containing screens having a surface greater than 100 sq cm
  3. Lamps
  4. Large equipment
  5. Small equipment
  6. Small IT and telecommunication equipment

Medical equipment will fall within categories 4 (for equipment larger than 50 cm) and 5. Adds Vaughan: An exemption still exists for “… medical devices and in vitro diagnostic medical devices, where such devices are expected to be infective prior to end of life, and active implantable medical devices.”

Vaughn continues: starting with the directive’s entry into force, medical devices will be subject to a recovery target of 70% and a recycling target of 50%. These targets will be increased on 15 August 2015 to 75% and 55%, respectively. After the introduction of the new equipment categories on 15 August 2018, the recovery and recycling targets for medical devices will become 85% and 80%, respectively, for large equipment (category 4) and  remain at 75% and 55%, respectively, for small equipment (category 5).

“There is a greater emphasis on reuse, as well,” adds Vaughan. “Reuse of medical devices is a very sensitive subject. As in all things related to medical devices, patient and user safety must remain paramount.”

Vaughan also delves into new requirements for transactions conducted over the Internet and describes hurdles for companies shipping electrical and electronic equipment across national borders. Products shipped to developing countries, ostensibly for reuse, will be subject to increased oversight to prevent companies from taking advantage of more lax environmental regulations and, in fact, recycle their goods. The proposal, however, will create a new obstacle for device manufacturers who legitimately transport devices across borders on a regular basis for repair, reconditioning or investigation.

For more on this, go to the Eucomed blog.

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